01 1Apotex Pharmachem
01 1TOFACITINIB CITRATE
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-30
Pay. Date : 2018-03-29
DMF Number : 32547
Submission : 2018-03-29
Status : Active
Type : II
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Apotex Inc, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is TOFACITINIB CITRATE, with a corresponding US DMF Number 32547.
Remarkably, this DMF maintains an Active status since its submission on March 29, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 30, 2018, and payment made on March 29, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
